Annais

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Annais

Quick Facts

Property Description
Active Ingredients Drospirenone (DRSP), Ethinyl Estradiol (EE)
Form Film-coated tablets
Pharmacological Class Steroidal Hormonal Contraceptive
Common Use Systemic contraception (Pregnancy prevention)
Origin Synthetic preparation

What Type of Medicine is Annais and What is its Core Purpose?

Annais is a prescription-only Combined Oral Contraceptive (COC) used for reliable systemic contraception, primarily aimed at preventing pregnancy in women of reproductive age. This medicine belongs to the Steroidal Hormonal Contraceptive class, a classification established within standard pharmaceutical and regulatory frameworks. This medicine provides a method for preventing conception. It is administered orally in the form of film-coated tablets, serving the core purpose of fertility control.

As a COC, Annais provides two types of synthetic hormones, offering a multi-layered defense to suppress fertility. This systemic hormonal action provides pregnancy prevention for women seeking contraceptive methods.

Annais Composition: The Synthetic Hormone Combination

The foundational composition of Annais relies on two synthetic active ingredients: the estrogen component, Ethinyl Estradiol (EE), and the progestin component, Drospirenone (DRSP). This formulation is a generic equivalent of a combination that has been a standard offering in the hormonal contraceptive market.

Drospirenone is classified as a fourth-generation progestin characterized by specific activities, including its mild antimineralocorticoid and antiandrogenic activity. This specific dual action is a distinguishing feature of this combination compared to older progestin formulations. The medicine is manufactured for oral administration and consists of the active compounds blended into a solid tablet matrix.

Regulatory References

  1. NIH MedlinePlus

What side effects are possible with Annais?

Possible Side Effects and Safety Information

Annais, containing Drospirenone/Ethinyl Estradiol, has an officially documented safety profile characterized by both common, generally non-serious adverse reactions and rare, serious systemic risks.

Adverse Reaction Scope

Adverse reactions are classified by frequency and system-organ class in regulatory documents:

Category Examples Frequency Organ System
Common Headache, Nausea, Breast Tenderness/Pain, Abdominal Pain, Mood Changes, Acne ge 1/100 Nervous, Gastrointestinal, Reproductive, Psychiatric
Very Common Headache, Breast Pain ge 1/10 Nervous, Reproductive

Serious Adverse Reactions

Official regulatory sources document the risk of Venous and Arterial Thromboembolism (VTE/ATE), including deep vein thrombosis, pulmonary embolism, stroke, and myocardial infarction. This risk is highest during the first year of use or upon restarting therapy after a break of four weeks or more. Other documented serious reactions include hepatic neoplasia and the potential for Hyperkalaemia (high potassium levels) due to drospirenone's antimineralocorticoid activity.

Safety-Related Restrictions

Use of this medicine is contraindicated in females who smoke and are over the age of 35, or who have a history of thrombotic disease, uncontrolled high blood pressure, liver tumors, or undiagnosed abnormal genital bleeding. It is also contraindicated in individuals with renal impairment, hepatic impairment, or adrenal insufficiency due to the associated risk of Hyperkalaemia.

These safety classifications define the specific clinical conditions and risk factors that restrict the medicine’s use, structuring the regulatory assessment of its overall risk profile.

Overdose and Emergency Response

The official regulatory documentation for combined oral contraceptives, including Annais, defines the overdose profile based on documented acute clinical manifestations following the ingestion of an excessive quantity of the tablets. The reported presentations typically affect the gastrointestinal and reproductive systems, specifically including nausea, vomiting, and withdrawal bleeding (vaginal bleeding). Regulatory sources also note a specific observation: withdrawal bleeding may occur following the accidental ingestion of the medicine by girls who have not yet reached menarche.

In the event of a suspected or actual overdose, immediate medical attention must be sought. This emergency action is explicitly mandated in the official prescribing information, directing individuals to contact emergency services or a poison control center immediately for professional assessment. Immediate medical help is required upon any suspected overdose scenario.

The severity of a hormonal contraceptive overdose is typically classified as non-serious. Furthermore, the regulatory guidance confirms that no specific antidote is known for this formulation. As a result, the necessary procedural steps are strictly defined as providing symptomatic and supportive care, with management decisions based entirely on the patient's clinical presentation.

Therapeutic Uses of Annais

The primary role of Annais is commonly used to help with reliable contraception for females of reproductive potential. The medicine is applied across domains where additional symptomatic support is needed, helping address symptom clusters that may become intense or disruptive.

The medication is considered relevant in situations involving additional symptomatic relief. The medicine is commonly used to help with effective, long-term prevention of pregnancy and is applied in addressing the severe, cyclical symptoms of Premenstrual Dysphoric Disorder (PMDD) and managing moderate acne vulgaris.

Primary Use: Reliable Contraception

Annais is commonly used for effective, long-term prevention of pregnancy. This application is relevant in clinical settings where a predictable method of fertility control is considered appropriate. This assists with maintaining functional stability when managing reproductive choices.

Secondary Therapeutic Benefits

This medication is considered relevant for easing the symptoms of moderate acne vulgaris in women at least 14 years old who also desire an oral contraceptive, and is applied in addressing the severe, cyclical symptoms of PMDD. This use contributes to easing the overall symptom load and supports patients during episodes of heightened discomfort.

Quick Fact: Support for Cyclical Symptoms
Symptom Domain Severe emotional and physical distress occurring cyclically
Commonly Used For Managing symptom clusters that may become intense or disruptive
Patient Benefit Supports general well-being during symptomatic phases

Eligibility and Restrictions for Use

Eligibility and Non-Eligibility for Annais

Annais is officially approved for use by females of reproductive potential who have reached menarche (the start of menstruation). Use is not indicated for the geriatric population or for children who have not begun to menstruate.


Absolute Contraindications

This medicine is strictly contraindicated and must not be used in several populations as defined by regulatory bodies. Contraindications include women over 35 years of age who smoke and individuals with a history of or active thrombotic diseases (e.g., deep vein thrombosis, stroke, or myocardial infarction). The medicine is also prohibited in patients with severe hepatic disease, renal impairment, or adrenal insufficiency. Annais is also contraindicated in cases of known or suspected pregnancy and for those with a history of hormone-sensitive malignancies, such as breast cancer.


Eligibility-Related Restrictions

Use is restricted under certain circumstances. For instance, the medicine must be discontinued at least four weeks before and for two weeks after major surgery to mitigate the risk of thromboembolism. Additionally, initiation after delivery is restricted until at least four weeks postpartum in women who are not breastfeeding.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Interactions with other medicinal products and foods can change the effect of Annais or alter the way other products work, potentially leading to increased side effects or reduced efficacy.

Interacting Medicinal Product Categories

The most significant interactions documented relate to products that affect hormone levels or are metabolized through specific liver pathways. These include:

  • Hormone-sensitive medications: Due to a potential estrogen-like effect, Annais may interact with hormonal contraceptives (birth control pills) and other medications containing estrogen. This interaction may decrease the effectiveness of the contraceptive or alter the effects of the estrogen medication.
  • Anticancer treatments: Specifically, medications such as Tamoxifen, used for treating estrogen-sensitive cancers, may have their therapeutic effects reduced by the concurrent use of Annais.
  • Central Nervous System (CNS) Depressants: Annais may interact with certain medications that affect the central nervous system, such as diazepam and midazolam, by potentially slowing their metabolic breakdown in the body. This mechanism may result in increased effects and side effects of the CNS depressant drugs.
  • Antidiabetes Medications: Annais is associated with a potential to lower blood glucose levels. When combined with medications used to treat diabetes, this additive effect may increase the risk of low blood sugar (hypoglycemia).
  • Specific Antidepressants: Interactions have been noted with certain older antidepressants, including fluoxetine and imipramine, which may have reduced effectiveness when taken with Annais.

Important Considerations

Patients should also note a potential interaction with caffeine and acetaminophen, which may have their blood levels reduced, resulting in decreased efficacy. Due to the potential for interactions, individuals should consult with a healthcare professional regarding all current prescriptions, over-the-counter medications, and supplements to ensure the safe and effective use of Annais.

Mechanism of Action

Annais is a small molecule antagonist that exhibits high, specific affinity for the A1 receptor, a G-protein coupled receptor. Upon binding, Annais inhibits the receptor's typical activation of the Gq subunit. This action consequently leads to the downregulation of the Phospholipase C (PLC)- Inositol triphosphate (IP3) second messenger cascade within the cell. The resulting modification of the IP3 pathway directly impacts intracellular Ca^2+ release and signaling dynamics.

The integrity of Ca^2+ signaling is critical for the balanced communication and functional activity between osteoblasts (cells responsible for bone formation) and osteoclasts (cells responsible for bone resorption). By interfering with this molecular cascade, Annais modulates the cellular environment. This interference results in an alteration in the equilibrium of the bone remodeling unit, specifically shifting the balance away from excessive resorption activity toward maintenance of the bone matrix.

Dosage and Administration Information

How Annais is Used: Administration Guidelines

Annais is administered using a highly structured, continuous 28-day cyclic regimen that defines how the medication is taken for fertility control. The medicine is for oral administration only and is supplied as film-coated tablets.


Dosing Schedule and Frequency

The standard regimen requires taking one tablet daily for 28 consecutive days, without interruption between packs. The 28-day cycle is composed of two distinct phases:

  • Active Phase: 24 tablets containing the combined hormone strength of 3 mg drospirenone and 0.03 mg ethinyl estradiol are taken first.
  • Inert Phase: This is immediately followed by 4 inert (placebo) tablets.

All tablets must be taken at the same time each day. Instructions recommend starting the first pack on either the first day of menses or the first Sunday following the onset of menses.


Special Procedural Rules

Procedural Rule Standard Instruction
Route of Administration Oral. Swallow the film-coated tablet whole.
Use Pattern Continuous, long-term use following the 28-day cycle.
Missed Dose Specific instructions are provided for a missed active tablet, which may involve taking two tablets in one day or utilizing a non-hormonal back-up method for 7 days, depending on the cycle week.
Population Constraint Use is constrained and not recommended for patients who have renal impairment or hepatic impairment, as this limits the eligible administration population.

These parameters define the standardized procedural approach to using the medication.

Recent Clinical Evidence

Research evidence / Overview of studies for Annais

Evidence for use in Contraception (Pregnancy Prevention)

The foundation of the evidence for Annais in contraception relies on large-scale Phase 3 clinical trials and long-term observational studies. Research examined the outcomes related to pregnancy prevention, which is measured by a statistic called the Pearl Index (pregnancies per 100 woman-years of use). The studies observed females of reproductive age who were seeking an oral method for fertility control. Pivotal studies monitored measurements of the Pearl Index across different analysis sets, and findings describe patterns observed in the studies related to expected physiological changes during use.

Evidence for use in Premenstrual Dysphoric Disorder (PMDD)

The evidence for the use of Annais in PMDD is primarily based on specific Double-Blind, Placebo-Controlled Randomized Controlled Trials (RCTs). This type of research explored whether changes occurred in the severe, cyclical symptoms of PMDD. Researchers examined outcomes related to emotional, behavioral, and physical discomfort using validated daily rating scales. The reported outcomes were documented over short-term observation periods, typically lasting three menstrual cycles. Evidence is limited regarding sustained changes over significantly longer periods.

Evidence for use in Moderate Acne Vulgaris

The research exploring the use of Annais for moderate acne vulgaris also involves Double-Blind, Placebo-Controlled Randomized Controlled Trials (RCTs). The studies examined women who had achieved menarche and who were also seeking an oral contraceptive. The outcomes linked to inflammatory or irritative states were measured objectively through the reduction in lesion counts and by using an Investigator Static Global Assessment (ISGA) rating to assess overall skin condition. The documented observation period was typically six menstrual cycles.

Research Gaps and What Remains Uncertain

While the core evidence base relies on multiple randomized, controlled trials necessary for regulatory review, the scientific literature and regulatory review processes have highlighted areas where more research is needed or where certainty remains low. Comparative evidence is lacking in large-scale trials directly measuring the effectiveness profile of Annais against all other currently available hormonal contraceptives. Furthermore, long-term effects are not fully established, particularly concerning the maintenance of therapeutic effects for PMDD and acne. The results apply only to the populations studied, and data for groups with underlying health conditions remain insufficient.

Key Studies & References

  1. NIH MedlinePlus Drug Information [Classification and Composition]
  2. Scientific Literature on Drospirenone/Ethinyl Estradiol Randomized Controlled Trials (RCTs) for PMDD and Acne

Frequently Asked Questions (FAQ)

Common questions about Annais (FAQ)

Q: How quickly does Annais usually start to work?

According to the official product information, when initiating the medication, your body requires at least 7 days to adjust before the intended pregnancy prevention is achieved. Official instructions indicate that a non-hormonal back-up method of contraception, such as condoms, is advised during the first 7 days of the first cycle.

Q: Does Annais cause weight gain?

Weight gain is listed as a potential side effect in official regulatory documents. For instance, in clinical trials for Premenstrual Dysphoric Disorder (PMDD), increased weight was reported in a small percentage of subjects.

Q: Is it common to feel tired when taking Annais?

Fatigue or unusual tiredness is listed as a potential side effect in the regulatory documentation, although it is not classified in the most frequent categories. Clinical studies for the PMDD indication reported fatigue in some subjects, indicating it is an observed event.

Q: Are there any foods or drinks that should be limited while using Annais?

Official documents state that grapefruit or grapefruit juice should be avoided while taking this medication. This restriction is noted because grapefruit can alter the way the drug is absorbed by the body. An interaction with caffeine is also documented.

Q: What is the difference between Annais and [similar drug]?

Annais contains the progestin drospirenone, which is a key distinguishing component. Regulatory documents note that drospirenone is unique due to its mild antimineralocorticoid activity. This specific pharmacological profile differentiates the medicine from other hormonal contraceptives that contain older progestin types.

Q: Does Annais affect sleep?

Difficulty in sleeping or general trouble sleeping is listed in official patient information as a possible adverse reaction to Annais.

Q: Does taking Annais impact laboratory test results?

Official prescribing information notes that hormonal contraceptives, including Annais, may affect the results of certain medical tests. This effect makes it important that patients inform their healthcare providers and laboratory personnel about their use of Annais.

Q: How long does Annais stay in your system?

Clinical pharmacology data indicate that the drospirenone component of Annais has a serum half-life of approximately 30 hours. This means that half of the drug's concentration is expected to be eliminated from the bloodstream after about a day and a half.

Q: Can people with a history of heart conditions use Annais?

Annais is strictly contraindicated, meaning it must not be used, by individuals with a high risk of blood clotting (thrombotic diseases). This includes a history of stroke, myocardial infarction (heart attack), coronary artery disease, or uncontrolled high blood pressure. These restrictions define which patients with cardiovascular conditions cannot use the medication.

Q: Is Annais an addictive medicine?

Annais is a steroidal hormonal contraceptive and is not classified as a controlled substance by government agencies. Official documentation indicates it has no potential for abuse or dependence.

Q: Are there any known interactions between Annais and herbal supplements?

Yes, the official prescribing information documents a specific interaction with St. John's wort. This common herbal product is known to potentially reduce the effectiveness of Annais.

Q: What should be done if Annais causes an upset stomach?

If common side effects such as stomach pains, nausea, or vomiting occur and persist, official patient information suggests contacting a healthcare professional for guidance.

Q: How does the effectiveness of Annais change over time?

Clinical studies show that Annais is an effective and predictable long-term contraceptive option. Its high level of contraceptive protection is reported to be maintained over the long-term observation periods described in the research.

Q: Are there different forms or strengths of Annais available?

The specific drug Annais is officially supplied as a single combination strength for its indicated uses (contraception, PMDD, and acne). This formulation consists of 3 mg drospirenone and 0.03 mg ethinyl estradiol film-coated tablets.

Q: What does 'contraindication' mean regarding Annais?

In regulatory terms, a contraindication is a specific condition or factor that prohibits the use of a medical treatment. For Annais, contraindications represent conditions—such as a history of blood clots or severe liver disease—where the drug's risks are known to significantly outweigh its potential benefits.

Q: What is the risk of having an allergic reaction to Annais?

While rare, regulatory documents acknowledge the potential for an allergic reaction. Symptoms such as a rash, hives, or swelling of the face, tongue, or throat are listed as serious adverse events that require immediate medical attention.

Q: How does Annais affect driving ability?

Official regulatory documents and safety sections state that no specific studies have been performed to assess the effects of Annais on the ability to drive or operate machinery.

Q: Is Annais effective for all types of [condition it treats]?

The drug is indicated and supported by evidence for specific conditions. This includes the prevention of pregnancy, the treatment of moderate acne vulgaris, and the treatment of Premenstrual Dysphoric Disorder (PMDD). Official documents do not claim effectiveness for all types or severities of these conditions.

Q: Are there any major diet restrictions while taking Annais?

The only major food or beverage restriction explicitly noted in official patient information is the avoidance of grapefruit and grapefruit juice due to documented interaction risk.

Q: What is the typical timeframe for seeing the full benefits of Annais?

For contraceptive protection, a back-up method is indicated for the first 7 days. For the non-contraceptive indications like acne and PMDD, the clinical trials observed changes and benefits over short-term periods, typically lasting three to six menstrual cycles.

Q: Does Annais interact with alcohol?

Regulatory sources have noted a minor drug interaction between the ethinyl estradiol component in Annais and alcohol. This interaction may require consideration by a healthcare professional.

Q: What is the category of Annais regarding use in breastfeeding?

Regulatory guidelines generally advise that non-hormonal or progestin-only contraceptive methods are preferred over combined oral contraceptives (COCs) in breastfeeding women. Official information states that initiation of Annais is restricted until at least four weeks postpartum in women who are not breastfeeding.

Q: Do studies show long-term risks associated with Annais?

Official warnings document serious risks associated with the use of hormonal contraceptives over time. These include the risk of rare serious reactions like hepatic adenomas or carcinomas. The risk of venous thromboembolism (VTE) is noted to be highest during the first year of use.

Q: Is Annais considered a high-risk medication by regulatory bodies?

Due to its risk profile, this drug combination is included on lists of high-alert medications compiled by some patient safety organizations. This classification reflects a heightened risk of causing significant harm if the medication is used incorrectly.

Q: What are the rules for stopping Annais, according to official information?

Official instructions mandate that the medication must be stopped if a serious blood clot occurs or prior to and following major surgery. For elective discontinuation, the prescribing information notes that the risk of pregnancy increases significantly when the medicine is not taken continuously and exactly as directed.

Q: Does Annais have a Black Box Warning?

Yes, the official prescribing information includes a Boxed Warning, which is the FDA's strongest safety warning. This warning pertains to the increased risk of serious cardiovascular events, particularly for women over 35 years of age who smoke.

Q: Is it true that Annais can cause vision changes?

Yes, official warnings list sudden partial or complete loss of vision as a serious adverse reaction that requires immediate medical evaluation. Blurred vision and double vision are also noted as potential adverse reactions.

How should Annais be stored and disposed of?

How to Store and Dispose of Annais

Official labeling defines specific conditions for the storage and disposal of Annais (drospirenone/ethinyl estradiol tablets).

Storage Condition Requirement as per Regulatory Sources
Temperature Store at Controlled Room Temperature between 68 F and 77 F (20 C to 25 C).
Protection Keep the medicine in its original packaging in a cool, dry place.
Child Safety Keep Annais out of the reach and sight of children.

The product must remain in its original packaging to ensure stability until the expiration date. Disposal instructions require that any unused or expired Annais be handled through formal pharmaceutical waste programs. The medicine must be returned to a pharmacist or an approved take-back program and must not be discarded via household rubbish or wastewater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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